Comparing surgery plus chemotherapy to chemoradiotherapy followed by surgery plus chemotherapy for recurrent rectal 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 phase III trial aims to determine if preoperative chemoradiotherapy followed by surgery and adjuvant chemotherapy improves local relapse-free survival compared to the standard treatment of surgery plus adjuvant chemotherapy for patients with locally recurrent rectal cancer. A total of 110 patients will be randomly assigned to one of the two treatment groups over a period of six years across 43 institutions in Japan. The primary focus is on local relapse-free survival, while secondary endpoints include overall survival, relapse-free survival, and quality of life post-surgery.

Why it matters

Who can join: the full rules

Inclusion Criteria:

1. Histopathologically proven adenocarcinoma or adenosquamous carcinoma on the resected specimen of the initial rectal cancer or endoscopic biopsy from the initial rectal cancer.
2. The main tumor location of the initial rectal cancer is upper, middle or lower rectum, or anal canal.
3. Either of the following treatments was performed for the initial rectal cancer, and classified as R0/1 or ER (Endoscopical R)0/1 on pathological diagnosis.

   i) Surgical resection (including local resection, with or without lymph node dissection).

   ii) Endoscopic resection.
4. Patients with distant metastasis during or after treatment for the initial rectal cancer, and radical surgical resection or radical radiotherapy performed more than 168 days before registration is eligible.
5. Recurrent rectal cancer diagnosed by any of the following modalities after treatment for the initial rectal cancer.

   i) The recurrent lesion is pathologically diagnosed. ii) Diagnosed as local recurrence by more than two modalities among contrast-enhanced CT, contrast-enhanced MRI, or positron emission computed tomography (PET).

   iii) Chronological progression of the lesion seen on more than one modality among contrast-enhanced CT, MRI, or PET.
6. The main tumor location is within pelvis as seen on contrast-enhanced CT and MRI if recurrent lesion is multiple, or recurrent lesions spread outside of pelvis continuously.
7. LRRC is diagnosed with no following condition. i) Judged as resectable endoscopically. ii) Depth of invasion within the muscularis propria as seen on contrast-enhanced CT, MRI, or PET in case of recurrence inside the intestine iii) Solitary ovarian metastasis. iv) Recurrence of the common iliac lymph node alone.
8. LRRC is diagnosed as resectable, and all the following conditions must be fulfilled:

   i) No distant metastasis on contrast-enhanced CT (cM0). ii) Estimated circumferential resection margin \>0 mm. iii) Leg amputation not required. iv) Preservation of the first sacral nerve possible.
9. No prior surgery for recurrent rectal cancer.
10. No prior pelvic irradiation for any malignancies.
11. A patient who has received systemic chemotherapy for any malignancies and the final dose was administered more than 14 days ago.
12. Age at registration is 20 to 80 years old.
13. Eastern Cooperative Oncology Group (ECOG) performance status is 0 or 1.
14. Measurable lesion is not mandatory.
15. Adequate oral intake.
16. Sufficient organ function. i) Neutrophil count \>= 1,500/mm3 ii) Hemoglobin \>= 9.0 g/dL iii) Platelet count \>= 100,000/mm3 iv) Total Bilirubin =\< 2.0 mg/dL v) Aspartate aminotransferase (AST) =\< 100 U/L vi) Alanine Aminotransferase (ALT) =\< 100 U/L vii) Cr =\< 1.5 mg/dL
17. Open surgery or laparoscopic surgery is planned.
18. Written informed consent is obtained.

Exclusion Criteria:

1. Synchronous or metachronous (within 5 years) malignancies except cancer with 5-year relative survival rate of 95% or more such as carcinoma in situ, intramucosal tumor, or early stage cancers.
2. Infections requiring systemic treatment.
3. Body temperature higher than 38 degrees Celsius at registration.
4. Pregnant female, female within 28 days post-parturition, or lactating mother. Men with partners planning conception in the near future.
5. Severe psychological disease.
6. Continuous systemic corticosteroid or immunosuppressant treatment.
7. Uncontrollable diabetes mellitus.
8. Uncontrollable hypertension.
9. Unstable angina pectoris, or history of myocardial infarction within 6 months.
10. Uncontrollable valvular disease, dilated cardiomyopathy, or hypertrophic cardiomyopathy.
11. Positive serum Hepatitis B (HB)s antigen or serum Hepatitis C Virus (HCV) antibody.
12. Positive serum HIV antibody.
13. Interstitial pneumonia, pulmonary fibrosis, or severe emphysema on chest CT.

Where it's running

• Chiba Cancer Center
  Chiba, Japan Recruiting
• Gifu University School of Medicine
  Gifu, Japan Recruiting
• Hiroshima City Asa Citizens Hospital
  Hiroshima, Japan Recruiting
• Hiroshima City Hospital
  Hiroshima, Japan Recruiting
• Shimane University Faculty of Medicine
  Izumo, Japan Recruiting
• Ishikawa Prefectural Central Hospital
  Kanazawa, Japan Recruiting

Study contacts

• Principal investigator: Masaaki Ito, MD, PhD — National Cancer Center Hospital East
• Study coordinator: Yuichiro Tsukada, MD,PhD
• Email: yutsukad@east.ncc.go.jp
• Phone: +80-4-7133-1111

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

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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.