Online adaptive radiotherapy vs standard radiotherapy after surgery for cervical or endometrial cancer

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 is a national, investigator-initiated, open-label, randomized non-inferiority trial comparing moderately fractionated online adaptive radiotherapy to conventional image-guided IMRT in post-operative cervical or endometrial cancer patients. Participants are randomized with stratification by center, cancer type, and receipt of concurrent chemotherapy. Primary endpoint is acute treatment-related toxicity, with secondary endpoints including late toxicity, 3-year local control, distant metastasis, various survival metrics, quality of life, and cost-effectiveness. Eligible patients are adults 18–75 with good performance status who had radical surgery for cervical or endometrial cancer and meet specified pathology-related criteria. The study plans to enroll 228 participants across participating sites, led by Xiaorong Hou at Peking Union Medical College Hospital.

Why it matters

Who can join: the full rules

Inclusion Criteria:

1. Participants must be fully voluntary and have decision-making capacity, providing written informed consent within 30 days prior to enrollment.
2. Age ≥18 years and ≤75 years.
3. ECOG performance status of 0-1, and expected to tolerate lying supine for half an hour.
4. Have undergone radical surgery for cervical cancer (procedure: radical hysterectomy + pelvic lymphadenectomy ± para-aortic lymphadenectomy) or surgery for endometrial cancer (procedure: total hysterectomy + bilateral salpingo-oophorectomy ± pelvic and/or para-aortic lymph node dissection/sampling or sentinel lymph node biopsy).
5. For participants with cervical cancer, the following criteria must be met:

(1)Pathologically diagnosed with cervical squamous cell carcinoma or adenocarcinoma.

(2)Must have at least one of the following high-risk factors; or have other risk factors requiring postoperative radiotherapy: High-risk factors: Pelvic lymph node metastasis, or positive surgical margin, or parametrial invasion.

Other risk factors: Middle or deep one-third stromal invasion, regardless of tumor size and LVSI status; Tumor size ≥4cm, regardless of depth of stromal invasion and LVSI status; Adenocarcinoma: Tumor size ≥2cm, or positive LVSI, regardless of depth of stromal invasion.

6.For participants with endometrial cancer, the following criteria must be met: Endometrioid adenocarcinoma: Grade 3 with superficial myometrial invasion, accompanied by substantial LVSI or age ≥70 years; Grade 2 with deep myometrial invasion, accompanied by substantial LVSI or age ≥60 years; Grade 3 with deep myometrial invasion; FIGO 2009 Stage II-IIIC1.

Non-endometrioid adenocarcinoma: FIGO 2009 Stage I-IIIC1 (serous carcinoma, clear cell carcinoma, mixed type).

7.Participants with high-risk factors may receive a vaginal brachytherapy boost following the completion of external beam radiotherapy.

8.Participants with high-risk cervical cancer must receive concurrent sensitizing chemotherapy for ≥4 cycles.

9.Participants must be eligible to receive sequential or sandwich adjuvant chemotherapy as planned.

Exclusion Criteria:

1. Presence of confirmed distant metastasis or para-aortic lymph node metastasis;
2. Requirement for extended-field radiotherapy encompassing the para-aortic region;
3. Initiation of radiotherapy exceeds the specified time limit after surgery: exceeding 6 months post-surgery if adjuvant chemotherapy was administered, or exceeding 3 months post-surgery if no adjuvant chemotherapy was administered;
4. History of previous abdominal or pelvic radiotherapy;
5. History of or concurrent secondary primary malignancy (except for non-melanoma skin cancer, papillary/follicular thyroid carcinoma, or carcinoma in situ of the breast);
6. History of underlying intestinal diseases such as ulcerative colitis or Crohn's disease;
7. Cervical cancer with pathological types such as adenosquamous carcinoma, small cell carcinoma, clear cell carcinoma, or other special types; Endometrial cancer with pathological types such as undifferentiated carcinoma, carcinosarcoma, or other special types;
8. Pregnant or lactating women;
9. Presence of active infection or fever;
10. Other severe comorbidities that may significantly compromise protocol compliance, such as uncontrolled cardiac disease requiring treatment, renal disease, chronic hepatitis, poorly controlled diabetes, psychiatric disorders, etc.

Where it's running

• Peking Union Medical College Hospital
  Beijing, Beijing Municipality, China Recruiting

Study contacts

• Study coordinator: Xiaorong Hou, Professor
• Email: houxr@pumch.cn
• Phone: +86 18612672203

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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.