Shorter radiation may be just as good for rectal cancer patients
NCT ID NCT07258797
First seen Jun 25, 2026 · Last updated Jun 27, 2026 · Updated 1 time
Summary
This study compares two standard radiotherapy approaches—short-course (1 week) and long-course (several weeks)—given before surgery to people with locally advanced rectal cancer. The goal is to see which one works better at shrinking tumors and is easier for patients to tolerate. About 150 participants will be randomly assigned to one of the two treatments, and their outcomes will be tracked.
What this could mean
Our plain-language read of the trial. This is informational only, not medical advice or a prediction.
- Active substance
- Radiotherapy (short-course or long-course) plus chemotherapy (modified FOLFOX6 or mFOLFIRINOX)
- What this could lead to
- If successful, this study could show that a shorter radiotherapy course is just as effective as the longer one, potentially reducing treatment burden for patients with rectal cancer.
- What could go wrong
- This is a single-institution study with 150 participants, so results may not apply broadly. Both treatments are standard, so no major breakthrough is expected.
This is an AI summary of the original study and may miss details. Read our disclaimer.
Study facts
What this study's own registry entry says, in plain language.
- Phase
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Not a phased trial
Phase numbers describe drug development. The registry uses this when they do not apply, as it does for trials of devices, procedures or behaviour changes, and for observational studies.
- Participants
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About 150 people
The number the study aims to enrol. It can still change while the study runs.
- Expected to start
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Dec 2025
An estimate. Start dates often move.
- Expected to finish
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Mar 2029
An estimate. End dates often move.
- Lead sponsor
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Other sponsor
The registry's catch-all category, for sponsors it does not file as a company, a government agency, or a research network.
Who can take part
This study's own entry requirements. Only the study team can say for certain whether you qualify.
- Ages
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18 to 75 years
- Sex
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Anyone
- Healthy volunteers
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Not accepted
This study is not open to healthy volunteers. The entry requirements below say who it is open to.
Show the full entry requirements Hide the full entry requirements
Copied word for word from the study's registry entry, so the wording is the study team's rather than ours.
Inclusion Criteria: 1. Histologically confirmed adenocarcinoma of the rectum 2. Locally advanced disease based on MRI including cT3-T4 and/or node positive disease (cN1 or N2) 3. Tumor located within 15 cm from the anal verge (confirmed by endoscopy or MRI) 4. ECOG performance status 0-2 5. Hemoglobin ≥ 9 g/dL 6. Absolute neutrophil count ≥ 1,500/mm³ 7. Platelets ≥ 100,000/mm³ 8. Total bilirubin ≤ 1.5 × ULN 9. Aspartate transaminase/Alanine transaminase ≤ 2.5 × ULN 10. Serum creatinine ≤ 1.5 × ULN or creatinine clearance ≥ 60 mL/min 11. Fit for neoadjuvant therapy and curative resection 12. Willing and able to provide written, informed consent 13. Baseline MRI and biopsy (even if done outside) must be reviewed and approved by the institutional radiology and pathology review board, requiring concurrence from two independent pathologists and two independent radiologists Exclusion Criteria: 1. Metastatic disease at presentation (distant nodes, liver, lung, peritoneum, etc.) 2. Prior pelvic radiotherapy or systemic chemotherapy for rectal cancer 3. Presence of synchronous malignancies or previous malignancy within 5 years except: Treated basal cell or squamous cell carcinoma of the skin, In situ cervical cancer, Active uncontrolled infection 4. Known HIV infection with CD4 \< 200 cells/μL, or active hepatitis B or C 5. Severe comorbid conditions precluding therapy (e.g., decompensated cardiac, hepatic, or renal disease) 6. Pregnant or breastfeeding women 7. Inability to comply with protocol requirements or follow-up schedule 8. Psychiatric illness or social situations that may limit compliance with study requirements
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Conditions
The condition(s) this trial relates to.
As listed by the trial registrant
The condition terms exactly as the trial's registrant entered them.
How to take part
Only the study team decides who joins. These are the ways to reach them.
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The places running it
1 site. The list below names each one and where it is.
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The official record
ClinicalTrials.gov lists the study team's own contact details, including names and phone numbers. We don't republish those.
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A doctor treating you
A doctor who knows your case can contact a study site on your behalf, and can tell you whether this study is worth pursuing at all.
Contacts and locations
Locations
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Rajiv Gandhi Cancer Institute and Research Centre
New Delhi, 110085, India
More trials for these conditions
Other studies related to the condition(s) this trial covers.
- New drug duo targets Hard-to-Treat colorectal cancer
- Can early rectal cancer be treated without removing the rectum?
- Immunotherapy before surgery shows promise for certain colorectal cancers
- New drug cocktail aims to shrink rectal tumors before surgery
- New study aims to Fine-Tune radiation for liver cancer spread
- Researchers track rectal cancer treatment responses