Comparing reduced and conventional radiotherapy doses for nasopharyngeal carcinoma

Is this trial a fit for you?

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

What this trial studies

This clinical trial aims to evaluate the effectiveness and safety of reduced dosage intensity-modulated radiotherapy (IMRT) compared to conventional dosage IMRT in patients with stage II-III nasopharyngeal carcinoma who are sensitive to induction chemotherapy. Patients will be randomized into two groups: one receiving reduced dose IMRT and the other receiving conventional dose IMRT, with both groups also undergoing two cycles of cisplatin chemotherapy. The study will assess the incidence of radiotherapy-related toxicities, quality of life, and tumor control rates. The trial is multicenter and open-label, ensuring a diverse patient population and robust data collection.

Why it matters

Who can join: the full rules

Inclusion Criteria:

1. Histologically confirmed non-keratinizing nasopharyngeal carcinoma (differentiated or undifferentiated type, i.e., WHO type II or type III).
2. Staged as T1-3N1-2M0, T2-3N0M0 (stage II-III) at diagnosis (according to the 8th AJCC edition).
3. Aged between 18-70 years.
4. Karnofsky scale (KPS)≥70.
5. Normal bone marrow function.
6. Evaluated as PR or CR after 3 cycles of GP induction chemotherapy.
7. EBV DNA copy number decreased to 0 copies/mL after 3 cycles of GP induction chemotherapy.
8. Normal liver and kidney function:

   1. total bilirubin, AST and ALT levels of no more than 2.5 times the upper normal limit;
   2. creatinine clearance rate of at least 60 mL/min or creatinine of no more than 1.5 times the upper normal limit.
9. Given written informed consent.

Exclusion Criteria:

1. Histologically confirmed keratinized squamous cell carcinoma (WHO type I) or basal squamous cell carcinoma.
2. Recurrent or metastatic nasopharyngeal carcinoma.
3. Evaluated as SD or PD after 3 cycles of GP induction chemotherapy.
4. EBV DNA copy number of more than 0 copies/mL after 3 cycles of GP induction chemotherapy.
5. Pregnancy or lactation (Pregnancy tests should be considered for women in childbearing age, and effective contraception should be emphasized during treatment.)
6. Other invasive malignant diseases in the past, other than cured basal cell skin carcinoma, squamous cell carcinoma, cervical carcinoma in situ.
7. Primary and regional lesions have been treated with chemotherapy or surgery (except diagnostic purpose)
8. Any severe disease, which may cause unacceptable risk factors or affect compliance with the trial, for example, unstable heart disease requiring treatment, kidney disease, chronic hepatitis, poorly controlled diabetes (fasting blood glucose \> 1.5×ULN), and mental illness.

Where it's running

• Sun Yat-sen University Cancer Center
  Guangzhou, Guangdong, China Recruiting
• Zhongshan People's Hospital
  Zhongshan, Guangdong, China Recruiting
• Cancer Center of Guangzhou Medical University
  Guangzhou, Guangdong, China Not yet recruiting
• Yuebei People's Hospital
  Shaoguan, Guangdong, China Not yet recruiting
• Wuzhou Red Cross Hospital
  Wuzhou, Guangxi, China Not yet recruiting
• National Cancer Centre Singapore
  Singapore, Singapore Not yet recruiting

Study contacts

• Study coordinator: Ming-Yuan Chen, MD, PhD
• Email: chmingy@mail.sysu.edu.cn
• Phone: 86-20-87343624

Similar studies

Other studies for the same condition or treatment. Recruiting studies are listed first.

• Induction chemotherapy with low-dose radiation and cadonilimab for locally advanced nasopharyngeal carcinoma

  This study will try adding low-dose radiation and the immune drug cadonilimab to induction chemotherapy before standard concurrent chemoradiotherapy in adults with newly diagnosed locally advanced nasopharyngeal carcinoma.

  Recruiting Phase 3 Sun Yat-sen University · Guangzhou, Guangdong and 2 other locations · NCT05941741

• Combining Toripalimab with Chemo-radiotherapy for Advanced Nasopharyngeal Cancer

  This study is testing if adding a new drug called Toripalimab to standard chemo-radiotherapy can help people with advanced nasopharyngeal cancer live longer and feel better.

  Recruiting at 2 sites Phase 3 Sun Yat-sen University · Guangzhou, Guangdong and 5 other locations · NCT04453813

• Targeted Induction Therapy for Stage III Unresectable EGFR Mutant NSCLC

  This trial tests a targeted induction approach using fumetinib with platinum-based chemotherapy and concurrent radiochemotherapy in adults with unresectable stage III EGFR-mutant NSCLC to see if this combo can improve outcomes before possible surgery.

  Recruiting Phase 2 Shanghai Pulmonary Hospital, Shanghai, China · Shanghai, Shanghai Municipality · NCT07742332

• Tracking fluid buildup (edema) in people with cancer

  This will try segmental bioelectrical impedance analysis to see if it can monitor local fluid buildup in cancer patients who have arm or leg swelling after radiotherapy or chemotherapy.

  Recruiting University of Copenhagen · Aalborg, The North Denmark Region · NCT07443618

• Outcomes for Oligometastatic and Oligorecurrent Cervical Cancer

  This registry will see if adding local treatments such as radiation or surgery to standard systemic therapy helps people with oligo‑metastatic or oligo‑recurrent cervical cancer live longer or avoid progression.

  Recruiting Tata Memorial Hospital · Mumbai, Maharashtra · NCT07400809

• Intestinal Low-Dose Radiotherapy plus Immunochemotherapy to Convert Borderline Resectable or Unresectable Esophageal Squamous Cell Carcinoma

  This study tests whether adding a very low dose intestinal radiotherapy with immunochemotherapy can make advanced esophageal squamous cell carcinoma operable for patients who can’t be surgically removed today.

  Recruiting Phase 2 Shantou University Medical College · Shantou, Guangdong · NCT07339488

How to take part

1. Review the eligibility criteria above with your treating physician.
2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.