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New treatment option for Rectal Cancer Patients
Official title Selective Total Mesorectal Excision Based on Intra-Operative Frozen Section From Local Excision in Rectal Cancer Undergoing Neoadjuvant Chemoradiotherapy
ClinicalTrials.gov ID: NCT07337811
What this study is testing
- What it's testing
- This study is a prospective, single-arm, phase II superiority trial to determine whether a selective organ-preserving strategy based on immediate intra-operative frozen-section results can achieve favorable 2-year local control while lowering morbidity in patients with low rectal cancer (tumor ≤5 cm from the anus) who have a near clinical complete response (near-cCR) or partial response (residual tumor \<2 cm) after radiation therapy. Population: Adults with primary rectal adenocarcinoma located ≤5 cm from the anal verge who, after neoadjuvant radiotherapy, are judged to have near-cCR or partial response (residual tumor \<2 cm).
A plain-language read of the study's public ClinicalTrials.gov listing. The study team confirms the details.
Who can take part
Ages 18 to 75
You may be able to join if
- Pathologically confirmed rectal adenocarcinoma.
- Neoadjuvant therapy based on radiotherapy; post-radiotherapy evaluation ≥8 weeks later shows near clinical complete response (near-cCR) or partial...
- Tumor distance from the anal verge ≤5 cm.
- Age 18-75 years.
- No synchronous multiple primary cancers.
You likely can't join if
- Age \ 75 years.
- Concurrent or previous malignancy within the past 5 years (except adequately treated basal-cell or squamous-cell skin carcinoma or carcinoma in situ...
- Emergency surgery required for bowel obstruction, perforation, or bleeding.
- Prior colorectal surgery that may compromise intestinal reconstruction.
- Need for en-bloc multivisceral resection.
- ASA physical status IV or V.
See the full eligibility criteria
- Pathologically confirmed rectal adenocarcinoma.
- Neoadjuvant therapy based on radiotherapy; post-radiotherapy evaluation ≥8 weeks later shows near clinical complete response (near-cCR) or partial response (PR) with residual tumor \<2 cm.
- Tumor distance from the anal verge ≤5 cm.
- Age 18-75 years.
- No synchronous multiple primary cancers.
- No contraindications to pre-operative radiotherapy or chemotherapy.
- Adequate organ function (cardiac, hepatic, renal, hematologic).
- Patient or legally authorized representative able to understand the study protocol, willing to participate, and provide written informed consent.
- Age \ 75 years.
- Concurrent or previous malignancy within the past 5 years (except adequately treated basal-cell or squamous-cell skin carcinoma or carcinoma in situ of the cervix).
- Emergency surgery required for bowel obstruction, perforation, or bleeding.
- Prior colorectal surgery that may compromise intestinal reconstruction.
- Need for en-bloc multivisceral resection.
- ASA physical status IV or V.
- Pregnant or lactating women.
- a) Women of child-bearing potential with a positive serum pregnancy test at baseline or who have not undergone pregnancy testing; post-menopausal women must have been amenorrheic for ≥12 months.
- b) Men or women of reproductive potential unwilling to use effective contraception throughout the study period.
- Severe psychiatric illness precluding informed consent or compliance.
- Severe COPD, interstitial lung disease, or ischemic heart disease precluding safe surgery.
- Continuous systemic corticosteroid therapy within 1 month before enrolment.
- Contraindications to laparoscopic surgery.
- Patient or legally authorized representative unable to understand the study conditions and objectives.
The study team makes the final eligibility decision.
Where it's taking place
- Guangzhou, Guanggong, China
Questions & answers
Do participants get paid in this trial?
This listing doesn't specify compensation. Many trials still reimburse travel or offer a stipend, so it's worth asking the study team when you connect.
Is it free to join, and do I need insurance?
Searching and applying through BridgeMD is free. In clinical trials the study-related treatment and visits are generally provided at no cost to you. You usually don't need insurance to take part - confirm specifics with the study team.
How long does this study last?
The listing doesn't state an exact length. The study team walks you through the schedule and number of visits before you decide to enroll.
Who can join this trial?
This study is enrolling all sexes, 18 years to 75 years. The study team makes the final eligibility decision.
Where is this trial taking place?
Study sites include Guangzhou, Guanggong, China. Enter your location above to see the nearest site and check your eligibility.
Explore other conditions
BridgeMD is an information and trial-matching tool - not medical advice, and not the study sponsor. Details come from ClinicalTrials.gov; the study team decides eligibility.