Phase II Trial of Doxycycline with Radiotherapy for Rectal Cancer

Phase 2

• Conditions: Rectal Cancer; Cancer - Bowel - Back passage (rectum) or large bowel (colon)

• Registration Number: ACTRN12620000815965
• Lead Sponsor: Dr Natalie Briggs

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Study Start: 2020-08-14
• Last Update Posted: 24 August 2020

Recruitment & Eligibility

• Status: ot yet recruiting
• Sex: All
• Target Recruitment: 40

Inclusion Criteria

1. Pathologically-confirmed rectal adenocarcinoma.
2. Magnetic resonance imaging (MRI) stage T3-4, and/or N1-2, or full thickness low T2 lesions where R0 resectability is in doubt.
3. ECOG performance status of 0–2.
4. Adequate liver function on blood tests taken within four weeks of commencing doxycycline (e.g. ALT/AST <3 x ULN, bilirubin <1.5 x ULN).
5. Surgery planned to occur within 3 weeks of starting SCRT.
6. Willing and able to comply with all trial requirements, including treatment and timing and/or nature of required assessments.
7. Signed, written informed consent.

Exclusion Criteria

1. Received chemotherapy for their rectal cancer prior to SCRT;
2. Allergy to doxycycline.
3. Currently taking medications with which doxycycline is known to have clinically-significant drug-drug interactions including systemic retinoids, oral antacids, oral iron or calcium, carbamazepine, phenytoin, enzalutamide, lithium, ergotamine, diuretics, oral contraceptive pill, quinapril, rifampicin, warfarin, methotrexate, st johns wort, ciclosporin.
4. Myasthenia gravis;
5. Concurrent illness, including severe infection that may jeopardise the ability of the patient to undergo the procedures outlined in this protocol with reasonable safety.
6. Serious medical or psychiatric conditions that might limit the ability of the patient to comply with the protocol.
7. Prior high dose radiotherapy to the pelvis.
8. Pregnancy, lactation, or inadequate contraception. Women must be post-menopausal,
infertile, or use a reliable means of contraception. Women of childbearing potential must
have a negative pregnancy test done within 7 days prior to starting treatment. Men must have been surgically sterilised or use a barrier method of contraception.

Study & Design

• Study Type: Interventional
• Study Design: Not specified